FDA approves trial to advance treatment for Hereditary Spastic Paraplegia (HSP)
The trial will be conducted in the United States at Boston Children’s Hospital and will assess the safety, tolerability, and…
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USFDA
Strides Pharma receives USFDA approval for Celecoxib Capsules in multiple strengths
Approval from USFDA allows Strides Pharma to market Celecoxib Capsules 100 mg, 200 mg, and 400 mg in the United States
SPARC announces submission of IND application for SBO-154 to USFDA
SBO-154 set to enter global Phase 1 clinical trial for treatment of advanced solid tumours
FDA drug approvals drop 15.44%, but smaller pharma leads innovation: GlobalData
GlobalData’s bio/pharmaceutical outsourcing report highlights the reliance of smaller pharma companies on CDMOs for production,…
Cipla, Formosa sign multi-regional licensing deal for Clobetasol Suspension
This partnership aims to enhance ophthalmic care by providing treatment for post- operative inflammation and pain in patients…
Lupin gains tentative USFDA approval for Amifampridine Tablets
Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg of Catalyst Pharmaceuticals
Zydus receives final USFDA approval for Eluxadoline Tablets, 75 mg and 100 mg
Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea…
Zydus receives final USFDA approval for Ketoconazole Shampoo, 2%
Ketoconazole shampoo is an antifungal medication used to treat dandruff, fungal infections, and other skin conditions
Senores Pharma acquires 14 ANDAs from Dr. Reddy’s
The basket acquired comprises 13 ANDAs, which are approved by the USFDA and 1 ANDA, which is pending approval from the USFDA
USFDA approves novel non-opioid treatment for moderate to severe acute pain
Vertex Pharmaceuticals’ Journavx is the first drug to be approved in this new class of pain management medicines